BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRACISION HARMONIC SCALPEL HAND PIECE

    MDR report key: 1080396 · Received July 24, 2008

    Report

    Report Number
    3005075853-2008-00386
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 9, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    LFL
    PMA / PMN Number
    K002906
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HAND PIECE WAS RETURNED WITH THE MOUNT LOOSE AND THE NOSE CONE CRACKED. IT WAS TESTED ON A GENERATOR AND WAS FOUND TO BE FUNCTIONAL. THE HAND PIECE WAS DISASSEMBLED, A TORN ACOUSTIC ISOLATOR AND MOISTURE INGRESS WERE FOUND INSIDE THE INSTRUMENT. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. THE BATCH HISTORY RECORDS WERE REVIEWED WITH NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN LSH, THE DEVICE HAD INTERMITTENT ACTIVATION. THE CASE WAS COMPLETED WITHOUT ANY CONSEQUENCE. NO REPORTED PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRACISION HARMONIC SCALPEL HAND PIECE NONE LFL ETHICON ENDO-SURGERY, LLC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 GENERATOR